Vice President, Regulatory Affairs Job at Cabaletta Bio Inc (Philadelphia)

Vice President, Enzyme Therapies, Clinical Development

The Vice President, Enzyme Therapies, Clinical Development is the head of Resear...

Location

United States , San Rafael

Salary:

307840.00 - 461760.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

M.D. or M.D./PhD degree
15+ years of clinical research and development experience within pharmaceutical/biotech industry
8+ years in a leadership role leading and managing teams
Significant experience in late-stage clinical development within the biopharma industry
Demonstrated leadership of successful regulatory filings (NDA/BLA/MAA) for global clinical programs
Oversite of clinical development of a therapeutic area or multiple assets within a disease area
Excellent track record in building and growing high-performing teams
Excellent leadership and organizational skills, written and verbal communication skills, and interpersonal skills
Ability to effectively influence diverse internal and external customer groups at various levels
Demonstrated strategic and critical thinking, dynamic leadership, and team-building skills

Job Responsibility

Lead the development and execution of the Enzyme Therapies BU pipeline strategy
Oversee strategic selection and prioritization of assets
Build and lead a high-performing, cross-functional development strategy team
Partner with clinical, regulatory, commercial, medical, portfolio strategy, and business development functions
Drive late-stage clinical development, study design, and execution for pivotal and post-marketing studies
Work closely with business development to evaluate and integrate external innovation opportunities
Provide scientific and medical leadership for global regulatory filings and interactions
Serve as the primary communication liaison between the BU Leadership Team and R&D Leadership Team
Ensure key BU portfolio deliverables are planned, executed, and measured
Maintain strong relationships with investigators, regulators, key opinion leaders, and other external stakeholders

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

Associate Vice President, Clinical Data Management

The Associate Vice President, Clinical Data Management is a member of the Global...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s or master’s degree with 25+ years of data management experience
10 to 15 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment
Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM)
Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen’s global clinical development efforts
Expertise in AI/ML-driven data management solutions, automation, and advanced analytics
Understanding of clinical data standards (CDISC, SDTM, ADaM)
Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions
Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management
Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams

Job Responsibility

Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals
Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases
Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows
Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums
Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance
Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization
Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues
Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions
Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics
Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data

Vice President, Market Access, Commercial

Reporting to the Chief Commercial Officer, the Vice President, Market Access, Co...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

An advanced degree (Master's or Doctorate) in life sciences, business/finance, or a related field is preferred
15+ years of progressive experience in biopharma market access, pricing, health economics, or related areas, with a significant track record in senior leadership roles
Specific experience in cell and/or gene therapy, or launching other complex, rare disease therapies, is critical
Exceptional strategic thinking, commercial acumen, communication, negotiation, and leadership skills
A robust network within the biopharmaceutical industry, including relationships with key payers, hospitals and related thought leaders is vital
Strong team orientation and passion for continuous self-development

Job Responsibility

Develop and implement global and/or U.S. market access strategies that align with corporate goals and drive successful product launches
Cultivate relationships and lead negotiations with key stakeholders, including national and regional payers, government agencies (e.g., CMS), hospitals and policymakers, to secure and maintain optimal coverage and reimbursement
Lead the creation and communication of the product's value story, including clinical, economic, and health-related quality of life (HRQOL) value propositions, using evidence generation plans in partnership with Medical Affairs
Define and execute U.S. and global pricing strategies, balancing market competitiveness and access goals, while adhering to federal and state regulations
Partner with R&D, Commercial, Medical Affairs, Regulatory, Finance, and Supply Chain teams to ensure market access strategies are integrated into all stages of product development and commercialization
Proactively navigate evolving healthcare legislation and reimbursement models and optimize site-of-care strategies and provider logistics for the unique delivery of cell therapies (e.g., hospital-administered or specialty distribution models)
Establish and build a market access organization, overseeing a team of market access professionals and managing external advisors and consultants

What we offer

health and retirement, PTO, and stock option plans